NDA 021861

NOVARTIS

FDA Drug Application

Application #021861

Documents

• Letter: 2008-04-22
• Letter: 2012-02-27
• Letter: 2015-10-28
• Label: 2015-11-04
• Letter: 2010-01-26
• Letter: 2010-04-05
• Label: 2008-04-23
• Label: 2009-12-02
• Label: 2010-04-04
• Label: 2012-02-24
• Review: 2010-03-19
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2021-03-05
• Label: 2021-03-11

Application Sponsors

NDA 021861

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.665MG/SPRAY

1

PATANASE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2008-04-15	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2009-12-01	PRIORITY
EFFICACY; Efficacy	SUPPL	8	AP	2010-03-31	STANDARD
LABELING; Labeling	SUPPL	9	AP	2012-02-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-07-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	6
SUPPL	2	Null	8
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	0
SUPPL	15	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NOVARTIS

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(
    [0] => Array
        (
            [ApplNo] => 21861
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PATANASE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"0.665MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021861s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021861s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021861s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2010","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021861s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2009","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021861s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021861lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PATANASE","submission":"OLOPATADINE HYDROCHLORIDE","actionType":"0.665MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-03-04
        )

)